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Two months before the Foodand Drug Administration’s dead-line to decide whether to approveBiogen’s Alzheimer’s drug, adu-canumab, a council of senioragency officials resoundinglyagreed that there wasn’t enoughevidence it worked.
The council, a group of 15 offi-cials that reviews complex issues,concluded that another clinicaltrial was necessary before ap-proving the drug. Otherwise, onecouncil member noted, approvalcould “result in millions of pa-tients taking aducanumab with-out any indication of actually re-ceiving any benefit, or worse,cause harm,” according to min-utes of the meeting, obtained byThe New York Times.
“It is critical that the decision bemade from a place of certainty,”the minutes said.
The session, details of whichhave not been reported before,represented at least the third timethat proponents of approving adu-canumab in the F.D.A. had re-ceived a clear message that theevidence did not convincinglyshow the drug could slow cogni-tive decline.
On June 7, the F.D.A. green-lighted the drug anyway — a deci-sion that has been met withscathing rebuke from manyAlzheimer’s experts and other sci-entists and calls for investigationsinto how the agency approved atreatment that has little evidenceit helps patients.
How and why the F.D.A. wentahead and approved the drug —an intravenous infusion, mar-keted as Aduhelm, that the com-pany has since priced at $56,000 ayear — has become the subject ofintense scrutiny. Two congres-sional committees are investigat-ing the approval and the price.Much is still unknown, but an ex-amination by The Times hasfound that the process leading toapproval took several unusualturns, including a decision for theF.D.A. to work far more closely
with Biogen than is typical in aregulatory review.
Allegations about the collabora-tion prompted the F.D.A. to con-duct an internal inquiry after aconsumer advocacy group calledfor an inspector general’s investi-gation, according to documentsreviewed by The Times. Theagency has not disclosed the in-quiry.
Though the decision was con-sidered one of the F.D.A.’s mostconsequential and controversialin years, its leader, Dr. JanetWoodcock, the acting commis-sioner, was not involved in the de-liberations and left the final rulingto the head of the center responsi-ble for drug applications, theagency confirmed.
In written responses to ques-tions from The Times, the F.D.A.defended its decision to approvethe drug — the first forAlzheimer’s in 18 years.
“The agency did not lower itsstandards,” the F.D.A. said, add-ing, “and at no time considered do-ing so.”
The decision, the agency said,was “informed by science, medi-cine, policy, and judgment, in ac-cordance with applicable legaland regulatory standards.”
In written answers to ques-tions, Biogen said, “Biogen stands100 percent behind Aduhelm andthe clinical data that supported itsapproval.”
Alzheimer Drug ApprovedDespite Doubts It Worked
Two Inquiries Examine F.D.A.’s Process inCollaborating With the Drugmaker
This article is by Pam Belluck,Sheila Kaplan and Rebecca Robbins.
Dr. Janet Woodcock, the actingcommissioner of the F.D.A.
STEFANI REYNOLDS FOR THE NEW YORK TIMES
Continued on Page A15
VAN HORN, Texas — Jeff Be-zos, the richest human in theworld, went to space on Tuesday.It was a brief jaunt — rising morethan 65 miles into the sky aboveWest Texas — in a spacecraft thatwas built by Mr. Bezos’ rocketcompany, Blue Origin.
While Mr. Bezos was beaten tospace last week by Richard Bran-son, the British entrepreneur whoflew in a rocket plane from hiscompany Virgin Galactic, someanalysts consider Blue Origin,founded by Mr. Bezos more than20 years ago, to be a more signifi-cant contender in the future spaceeconomy. The company has ambi-tions of a scale far beyond shortflights for space tourists, and it isbacked by the entrepreneur whomade Amazon into an economicpowerhouse.
Lori Garver, who served as dep-uty administrator of NASA duringthe Obama administration, saidthat Mr. Bezos “has a huge, long-term vision that is multigenera-tional.” She added that his intentfor Blue Origin was to “competefor even higher stakes” in thegrowing business of space.
In 2017, Mr. Bezos announcedthat he would sell $1 billion of Am-azon stock a year to fund the
Bezos ReachesSpace but SeesIt as Small Step
By KENNETH CHANG
Continued on Page A17
PORT-AU-PRINCE, Haiti —Gerard Lovius falls asleep at nighton the floor of an empty classroomto the sound of gunfire. He and hisshellshocked neighbors startedliving there a month ago, aftergang members invaded his home,sending his terrified wife andthree children running into thestreets and leaving him with noth-ing: no money, no possessions, noteven a cellphone.
On Tuesday morning, Mr.Lovius was back at his job as astreet cleaner, tidying up beforethe day’s stately memorial forHaiti’s assassinated leader in theChamps de Mars, the capital’smain square. President JovenelMoïse would soon be laid to rest,and the sparring members of hisgovernment had just reached atruce, vowing to lead the countryanew.
But there was little peace in Mr.Lovius’s life. “We have hope onlyin God,” he said, hauling a wheel-barrow of trash up the street.
Haiti’s leaders have called thepolitical truce a new chapter, aturning of the page that, in thewords of the interim prime min-ister, shows “that we can actuallywork together, even if we are dif-ferent, even if we have different
Many Haitians Look to FutureWith Cynicism
By CATHERINE PORTER
Continued on Page A8
WARRENSVILLE HEIGHTS,Ohio — Nina Turner had justbelted out a short address to God’sTabernacle of Faith Church in thecadences and tremulous volumesof a preacher when the Rev. Timo-thy Eppinger called on the wholecongregation to lay hands on thewoman seeking the House seat ofgreater Cleveland.
“She’s gone through hell andhigh water,” the pastor said tonods and assents. “This is her sea-son to live, and not to die.”
On Aug. 3, the voters of Ohio’s11th District will render that judg-
ment and with it, some indicationof the direction the DemocraticParty is heading: toward the defi-ant and progressive approach Ms.Turner embodies or the reservedmold of its leaders in Washington,shaped more by the establish-ment than by the ferment stirringits grass roots.
Democrats say there is littlebroader significance to this indi-vidual House primary contest,
In Ohio, Democrats Fight Over Future of PartyBy JONATHAN WEISMAN A House Race Exposes
a Generational Split
Nina Turner, a progressive in greater Cleveland, is challenging the Democratic establishment.MADDIE McGARVEY FOR THE NEW YORK TIMES
Continued on Page A14
OAKLEY, Utah — The moun-tain spring that pioneers used towater their hayfields and now fillspeople’s taps flowed reliably intothe old cowboy town of Oakley fordecades. So when it dwindled to atrickle in this year’s scorchingdrought, officials took drastic ac-tion to preserve their water: Theystopped building.
During the coronavirus pan-demic, the real estate market intheir 1,750-person city boomed asremote workers flocked in fromthe West Coast and second-homeowners staked weekend ranches.But those newcomers need water— water that is vanishing as amegadrought dries up reservoirsand rivers across the West.
So this spring, Oakley, about an
hour’s drive east of Salt Lake City,imposed a construction moratori-um on new homes that would con-nect to the town’s water system. Itis one of the first towns in theUnited States to purposely stallgrowth for want of water in a newera of megadroughts. But it couldbe a harbinger of things to come ina hotter, drier West.
“Why are we building houses ifwe don’t have enough water?”said Wade Woolstenhulme, themayor, who in addition to raisinghorses and judging rodeos hasspent the past few weeks defend-
ing the building moratorium. “Theright thing to do to protect peoplewho are already here is to restrictpeople coming in.”
Across the Western UnitedStates, a summer of record-break-ing drought, heat waves andmegafires exacerbated by climatechange is forcing millions of peo-ple to confront an inescapablestring of disasters that challengethe future of growth.
Groundwater and streams vitalboth to farmers and cities are dry-ing up. Fires devour houses beingbuilt deeper into wild regions andforests. Extreme heat makesworking outdoors more danger-ous and life without air-condition-ing potentially deadly. While sum-mer monsoon rains have broughtsome recent relief to the South-west, 99.9 percent of Utah is
A Utah Town Halts Growth. It Lacks the Water.By JACK HEALY
and SOPHIE KASAKOVERecord Drought Hurts
Housing in the West:‘It’s Just Brutal’
Construction of new homes is on pause in Oakley, Utah, where access to water was one of the main draws for settlers in the 1800s.LINDSAY D’ADDATO FOR THE NEW YORK TIMES
Continued on Page A18
WASHINGTON — Thomas J.Barrack Jr., a close friend of for-mer President Donald J. Trump’sand one of his top 2016 campaignfund-raisers, was arrested in Cali-fornia on Tuesday on federalcharges of failing to register as aforeign lobbyist, obstruction ofjustice and lying to investigators.
A seven-count indictment ac-cused Mr. Barrack, 74, of using hisaccess to Mr. Trump to advancethe foreign policy goals of theUnited Arab Emirates and thenrepeatedly misleading federalagents about his activities duringa June 2019 interview.
Federal prosecutors said Mr.Barrack used his position as anoutside adviser to Mr. Trump’scampaign to publicly promote theEmirates’ agenda while solicitingdirection, feedback and talkingpoints from senior Emirati offi-cials.
Once Mr. Trump was elected,they said, Mr. Barrack invited sen-ior Emirati officials to give him a“wish list” of foreign policy movesthey wanted Washington to takewithin the first 100 days, first sixmonths, first year and by the endof Mr. Trump’s term, prosecutorssaid.
Among other key Emirati objec-tives, Mr. Barrack pushed for theTrump administration not to holda summit with Qatar, a rivalPersian Gulf power that was un-der a blockade that the Emiratesand Saudi Arabia, an Emirati ally,had organized, they said.
Mr. Barrack is latest in a longstring of former Trump aides,fund-raisers and associates toface criminal charges. The formerpresident’s company, the TrumpOrganization, and its chief finan-cial officer were indicted thismonth on state fraud and taxcharges. Mr. Trump’s former per-sonal lawyer, Michael D. Cohen,pleaded guilty in a hush-moneyscandal.
Mr. Trump pardoned his 2016campaign manager, Paul Man-afort, who had been convicted inthe special counsel’s investiga-tion, and his former chief strat-egist, Stephen K. Bannon, whohad been under federal indict-ment on charges that he misusedmoney he helped raise for a groupbacking Mr. Trump’s border wall.
Authorities have scrutinized a
U.S. AccusesTrump InsiderOf Hidden Ties
By SHARON LaFRANIEREand WILLIAM K. RASHBAUM
Continued on Page A18
Led by Giannis Antetokounmpo, Mil-waukee beat Phoenix, 105-98, for its firstchampionship in 50 years. PAGE B10
SPORTSWEDNESDAY B9-12
Bucks Win N.B.A. TitleMore people are buying the narrowboats used to navigate Britain’s water-ways and living on them. PAGE A4
INTERNATIONAL A4-10
Floating on England’s Canals
Johnson & Johnson and three giantdistributors were close to a tentativeagreement worth $26 billion that wouldpay for drug treatment. PAGE A14
NATIONAL A11-18
Settlement for Opioid LawsuitsFor many food truck operators and cartvendors, the ability to make meaningfulprofits depends on large numbers ofworkers returning to the office. PAGE B1
BUSINESS B1-8
The Future of Food TrucksTejal Rao celebrates all kinds of Califor-nia barbecue, from brisket and smokedchar siu, to cochinita pibil. PAGE D1
FOOD D1-8
Grilling on the West Coast
Jonathan Kanter, an antitrust lawyer,would be another critic of tech in apowerful regulatory position. PAGE B1
Biden Picks Top Antitrust CopAs the Delta variant rips through con-servative communities, many Republi-cans remain reluctant to confront vac-cine skeptics in their midst. PAGE A12
The G.O.P.’s Virus Problem
The I.O.C.’s president, Thomas Bach,used his clout to ensure the Gameswent on, even in a pandemic. PAGE B9
An Iron Grip on the OlympicsSome communities are weighing newinspection requirements for agingstructures, while others are stepping upenforcement of existing rules. PAGE A11
Worried About Old Buildings
After a woman, who was born a Sikh,married a Muslim man, her parentsaccused him of kidnapping. PAGE A6
Interfaith Unions in IndiaBret Stephens PAGE A23
OPINION A22-23
Stresses of the pandemic have movedmany independent-restaurant workersto start labor-union drives. PAGE D1
Unionizing Small Restaurants
Two documentaries tell stories set inthe region that avoid clichés or ster-eotypes, Isabelia Herrera says. PAGE C1
ARTS C1-6
More Depth in the Caribbean
Late Edition
VOL. CLXX . . . No. 59,126 © 2021 The New York Times Company NEW YORK, WEDNESDAY, JULY 21, 2021
Today, clouds and sunshine, show-ers, strong thunderstorm, high 86.Tonight, clearing, a bit cooler, low 67.Tomorrow, cloudy, less humid, high83. Weather map is on Page A24.
$3.00
